OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 description, usages, side effects, indications, overdosage, supplying and lots more!

OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50

OMP, INC.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN LOTION

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Octinoxate 7.5%, Zinc Oxide 10.5%

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m.; wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Other information

Store at controlled room temperature: 15°C–25°C (59°F–77°F). Protect this product from excessive heat and direct sun.

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Distributed by OMP, Inc., Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

OBAGI-C®
RX SYSTEM

Sun Shield

MATTE

Broad
Spectrum
SPF 50

Sunscreen
Lotion
PA+++

Net wt. 3 oz. (85 g.)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50

OCTINOXATE and ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62032-121
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
Zinc Oxide Zinc oxide 105 mg

Inactive Ingredients

Ingredient Name Strength
CYCLOMETHICONE 5
water
PEG-10 DIMETHICONE (600 CST)
PENTYLENE GLYCOL
stearyl alcohol
POLYOXYL 20 CETOSTEARYL ETHER
PHENYL TRIMETHICONE
PEG-40 STEARATE
SODIUM DIHYDROXYCETYL PHOSPHATE
hydrogenated palm glycerides
CITRIC ACID MONOHYDRATE
CETOSTEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
TROPOLONE
CHLORPHENESIN
XANTHAN GUM
POTASSIUM SORBATE
SODIUM BENZOATE
TETRAHEXYLDECYL ASCORBATE
UBIDECARENONE
EDETATE DISODIUM
METHYLISOTHIAZOLINONE
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
SQUALANE
POLYSORBATE 60

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62032-121-90 85 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-11-07


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